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Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Primary Purpose

Pediatric Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimegepant/BHV3000
Matching placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Migraine focused on measuring Migraine, Acute treatment, Phonophobia, Photophobia, Nausea, Pediatric, Children, Adolescent, Pediatric Migraine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.

  3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

    1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
    2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
    3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
  4. Verbally distinguish between migraine and other types of headaches.
  5. Participants must have a weight > 40 kg at the Screening Visit.
  6. Adequate venous access for blood sampling.
  7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.
  6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
  7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
  8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  9. Current diagnosis of viral hepatitis or a history of liver disease.
  10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Sites / Locations

  • Accel Research Sites-Neurology and Neurodiagnostics of Alabama, LLCRecruiting
  • Phoenix Children's HospitalRecruiting
  • Physicians Research GroupRecruiting
  • Advanced Research Center, Inc.Recruiting
  • Velocity Clinical Research, BanningRecruiting
  • ProScience Research GroupRecruiting
  • Neuro-Pain Medical CenterRecruiting
  • Sunwise Clinical Research, LLCRecruiting
  • Miller Children's & Women's Hospital Long BeachRecruiting
  • Children's Hospital Los Angeles, Division of Neurology
  • Children's Hospital Los Angeles-Children's Hospital Los Angeles Dept of Pharmacy
  • National Research Institute
  • Velocity Clinical Research - North HollywoodRecruiting
  • The Neurology GroupRecruiting
  • University of California, Davis Midtown Clinic
  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
  • University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
  • Pacific Clinical Research Management Group LLCRecruiting
  • Children's Hospital Colorado- lnvestigational Drug ServicesRecruiting
  • Children's Hospital ColoradoRecruiting
  • Colorado Springs Neurological AssociatesRecruiting
  • Boeson Research
  • Dinosaur Junction Pediatrics
  • Boeson Research - Grand Junction, CO
  • Connecticut Children's Medical CenterRecruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
  • Nemours Children's HealthRecruiting
  • Nemours Children's Hospital, DelawareRecruiting
  • Children's National Medical CenterRecruiting
  • Topaz Clinical Research, Inc.Recruiting
  • First Choice Neurlogy Espinosa Neuroscience InstituteRecruiting
  • Beautiful Minds Clinical Research Center
  • DeLand Clinical Research Unit
  • University Clinical Research - Deland, LLC dba Accel Research Sites
  • Sarkis Clinical TrialsRecruiting
  • Multi-Specialty Research Associates, Inc.Recruiting
  • Watson Clinic Center for Research, Inc.
  • Watson Clinic LLP
  • AppleMed Research Group, LLCRecruiting
  • Medical Research Center of Miami II, Inc
  • Genoma Research Group, Inc.
  • Brainstorm ResearchRecruiting
  • The Neurology Research GroupRecruiting
  • Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
  • Aqualane Clinical ResearchRecruiting
  • Collier Neurologic Specialists, LLCRecruiting
  • Coastal Clinical Research SpecialistsRecruiting
  • Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
  • Orlando Health Arnold Palmer Hospital for Children
  • Bioresearch Institute
  • Forcare Clinical ResearchRecruiting
  • Premiere Research Institute at Palm Beach NeurologyRecruiting
  • Children's Healthcare of Atlanta Center for Advanced PediatricsRecruiting
  • Rare Disease Research, LLCRecruiting
  • Pivotal Clinical Research & Associates, LLCRecruiting
  • CenExcel iResearch, LLCRecruiting
  • Chicago Headache Center & Research InstituteRecruiting
  • AMR-Baber Research IncRecruiting
  • Children's Clinical Research Center at Riley Hospital for Children at IU HealthRecruiting
  • Riley Hospital for Children at IU HealthRecruiting
  • Physicians Research GroupRecruiting
  • Options Research Group, LLCRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • College Park Family Care Center Physicians Group- Neurology Research Dept.Recruiting
  • Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
  • UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
  • University of Kentucky Hospital
  • Ochsner Clinic FoundationRecruiting
  • Neurology and Headache Center, Inc.
  • Boston Clinical TrialsRecruiting
  • MedVadis Research CorporationRecruiting
  • Michigan Head Pain & Neurological InstituteRecruiting
  • Outpatient Pediatric Neurology ClinicRecruiting
  • Spectrum Health Helen Devos Children's Hospital
  • Wellnow Urgent Care and Research
  • Beaumont Hospital Royal Oak CampusRecruiting
  • Precise Research CentersRecruiting
  • Sharlin Health Neuroscience Research CenterRecruiting
  • Clinvest Research, LLCRecruiting
  • Boeson ResearchRecruiting
  • Northwest PhysiciansRecruiting
  • Boeson Research HLNRecruiting
  • Helena Pediatric Clinic P.C.Recruiting
  • Boeson Research LLCRecruiting
  • Blue Moose PediatricsRecruiting
  • Boeson ResearchRecruiting
  • Alivation Research, LLC.
  • Children's Hospital & Medical Center
  • Dent Neurosciences Research CenterRecruiting
  • Prime Global Research, LLC
  • Northwell Health/ Division of Pediatric NeurologyRecruiting
  • NYU Langone Hospital-Long Island, Clinical Research CenterRecruiting
  • NYU Langone Hospital-Long Island, Pediatric NeurologyRecruiting
  • New York Neurology AssociatesRecruiting
  • Mount Sinai Hospital - Pharmacy DepartmentRecruiting
  • Columbia University Medical Center Research PharmacyRecruiting
  • Columbia University Pediatric Neuromuscular CenterRecruiting
  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research UnitRecruiting
  • The Neurological Institute of New YorkRecruiting
  • North Suffolk Neurology P.CRecruiting
  • Finger Lakes Clinical Research
  • New Hope Clinical ResearchRecruiting
  • Headache Wellness CenterRecruiting
  • Atrium Health Wake Forest BaptistRecruiting
  • Akron Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Drug Delivery - Cincinnati Children's Hospital IDS - Denise LagoryRecruiting
  • Velocity Clinical ResearchRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Nationwide Children's HospitalRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Neuro-Behavioral Clinical Research, Inc.Recruiting
  • IPS Research Company
  • Lynn Institute of TulsaRecruiting
  • Velocity Clinical Research, Grants PassRecruiting
  • Providence Pediatric NeurologyRecruiting
  • Providence St. Vincent Medical CenterRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Velocity Clinical Research-ProvidenceRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Tribe Clinical Research, LLCRecruiting
  • Velocity Clinical Research - GreenvilleRecruiting
  • Coastal Carolina Research CenterRecruiting
  • Holston Medical Group.
  • Holston Medical GroupRecruiting
  • Holston Medical Group
  • Access Clinical Trials, Inc.Recruiting
  • Dell Children's Medical CenterRecruiting
  • Child Neurology Consultants of Austin - South AustinRecruiting
  • Child Neurology Consultants of Austin - Central AustinRecruiting
  • BioBehavioral Research of AustinRecruiting
  • Houston Clinical Trials, LLCRecruiting
  • Future Search Trials of Dallas, LPRecruiting
  • Children's Medical Center, DallasRecruiting
  • Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)Recruiting
  • Cedar Health ResearchRecruiting
  • ANRC Research
  • North Texas Institute of Neurology and Headache
  • Pain and Headache Centers of TexasRecruiting
  • Houston Clinical Research,LLC.
  • NeuroCare PlusRecruiting
  • AIM Trials, LLCRecruiting
  • JBR Clinical ResearchRecruiting
  • Wasatch Clinical Research , LLC(Administrative Location)Recruiting
  • The University of Vermont Medical CenterRecruiting
  • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)Recruiting
  • Pediatric Research of Charlottesville, LLC (Regulatory Only)Recruiting
  • Pediatric Research of Charlottesville, LLCRecruiting
  • Children's Hospital of the King's DaughtersRecruiting
  • Children's Specialty Group, PLLC, Division of Childhood & Adolescent NeurologyRecruiting
  • National Clinical Research, Inc.Recruiting
  • Northwest Clinical Research CenterRecruiting
  • Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchRecruiting
  • Seattle Children's Hospital Investigational Drug Services
  • Seattle Children's Hospital
  • Seattle Children's Investigational Drug Service
  • Clinical Investigation Specialists, IncRecruiting
  • University Hospital
  • University HospitalRecruiting
  • University of Wisconsin-Madison
  • OCT Research ULCRecruiting
  • Diex Recherche Sherbrooke IncRecruiting
  • Alpha Recherche Clinique
  • Anhui Provincial HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • " The First Affiliated Hospital of Chongqing Medical University"Recruiting
  • " The First Affiliated Hospital of Chongqing Medical University"Recruiting
  • Lanzhou University Second Hospital LabRecruiting
  • Shenzhen Children's HospitalRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Hunan Children's HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • The Second People's Hospital of LianyungangRecruiting
  • Wuxi Children's HospitalRecruiting
  • Xuzhou Children's HospitalRecruiting
  • Affiliated Hospital of Jiangsu UniversityRecruiting
  • The First Hospital of Jilin University, Pediatric NeurologyRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Shaanxi Provincial People's HospitalRecruiting
  • Xi'an Gaoxin Hospital Neurology DepartmentRecruiting
  • Yan 'an University Xianyang HospitalRecruiting
  • Shandong Provincial Qianfoshan HospitalRecruiting
  • Liaocheng People's HospitalRecruiting
  • Children's Hospital of Zhejiang University School of MedicineRecruiting
  • The Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Affiliated Hospital of Chifeng UniversityRecruiting
  • Lu 'an People's HospitalRecruiting
  • Children's Hospital of ShanghaiRecruiting
  • The First Affiliated Hospital of Shihezi University School of MedicineRecruiting
  • Wuhan Children's HospitalRecruiting
  • Clinstile S.A. de C.V.Recruiting
  • Clinical Reseach Institute, S.C.Recruiting
  • Investigación Biomedica para el Desarrollo de Farmacos S.A. de C.V.Recruiting
  • "Hospital Universitario "" Dr. Jose Eleuterio Gonzalez"" Edificio Barragan 3er Piso CITEN
  • CIT-Neuropsique, S.C.Recruiting
  • Neurociencias Estudios Clinicos S.C.Recruiting
  • Unidad de Investigacion en Salud de Chihuahua S.C.Recruiting
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-DworakRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech SzczechowskiRecruiting
  • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w KrakowieRecruiting
  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.Recruiting
  • Euromedis Sp. z o. o.
  • Centrum Medyczne OporowRecruiting
  • Hospital Universitari Vall dHebronRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • CAP Balenyà
  • Instituto de Investigaciones del SuenoRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Clinico Universitario de ValladolidRecruiting
  • ProbarE i LundRecruiting
  • ProbarE i Stockholm ABRecruiting
  • Universitetssjukhuset Örebro
  • University Hospitals of Leicester - NHS Trust Research - Innovation Leicester General Hospital
  • Cognition Health - LondonRecruiting
  • Great Ormond Street Hospital GOSH for Children NHS Foundation Trust - Headache ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BHV3000 (active drug)

Placebo

Arm Description

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Matching 75 mg or 50 mg ODT placebo

Outcomes

Primary Outcome Measures

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
Pain freedom will be assessed in adolescent population (≥ 12 to < 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

Secondary Outcome Measures

To compare rimegepant with placebo for pain freedom in children and adolescents combined.
Pain freedom will be assessed in children and adolescents (≥ 6 to < 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom will be assessed in children (> 6 to < 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Use of rescue medication will be assessed using the numbers of participants that take rescue medication.
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.
The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.
To compare rimegepant with placebo for pain freedom in children.
Pain freedom will be assessed using the number of children (≥ 6 to < 12 years of age) that report no pain measured by a 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.
Freedom from the most bothersome symptom (nausea, phonophobia or photophobia) will be assessed using the number of participants that report the absence of MBS measured using a binary scale (0=absent, 1=present).
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.
The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.
Freedom from photophobia will be assessed by the number of participants that report the absence of photophobia post dose that reported the presence of photophobia at baseline.
To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.
Freedom from phonophobia will be assessed by the number of participants that report the absence of phonophobia post dose that reported the presence of phonophobia at baseline.
To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.
Freedom from nausea will be assessed by the number of participants that report the absence of nausea post dose that reported the presence of nausea at baseline.
To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.
Pain relief will be assessed using the number of participants that report a pain level of moderate or severe at baseline and then report a pain level of none or mild post dose.
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
Time to first report of pain relief will be based on the first time point a participant reports a pain level of none or mild.

Full Information

First Posted
November 23, 2020
Last Updated
October 10, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04649242
Brief Title
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Official Title
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
October 30, 2026 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Migraine
Keywords
Migraine, Acute treatment, Phonophobia, Photophobia, Nausea, Pediatric, Children, Adolescent, Pediatric Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BHV3000 (active drug)
Arm Type
Active Comparator
Arm Description
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching 75 mg or 50 mg ODT placebo
Intervention Type
Drug
Intervention Name(s)
Rimegepant/BHV3000
Intervention Description
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Matching 75 mg or 50 mg ODT placebo
Primary Outcome Measure Information:
Title
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
Description
Pain freedom will be assessed in adolescent population (≥ 12 to < 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Time Frame
2 hours post-dose
Secondary Outcome Measure Information:
Title
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
Description
Pain freedom will be assessed in children and adolescents (≥ 6 to < 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom will be assessed in children (> 6 to < 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
Description
Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Description
Use of rescue medication will be assessed using the numbers of participants that take rescue medication.
Time Frame
Within 24 hours and 48 hours of initial treatment
Title
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Description
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time Frame
2 to 24 hours post-dose
Title
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Description
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time Frame
2 to 48 hours post-dose
Title
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.
Description
The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo for pain freedom in children.
Description
Pain freedom will be assessed using the number of children (≥ 6 to < 12 years of age) that report no pain measured by a 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.
Description
Freedom from the most bothersome symptom (nausea, phonophobia or photophobia) will be assessed using the number of participants that report the absence of MBS measured using a binary scale (0=absent, 1=present).
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.
Description
The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.
Time Frame
Within 24 hours and 48 hours of initial treatment.
Title
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Description
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time Frame
2 to 24 hours post-dose
Title
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Description
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time Frame
2 to 48 hours post-dose
Title
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.
Description
Freedom from photophobia will be assessed by the number of participants that report the absence of photophobia post dose that reported the presence of photophobia at baseline.
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.
Description
Freedom from phonophobia will be assessed by the number of participants that report the absence of phonophobia post dose that reported the presence of phonophobia at baseline.
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.
Description
Freedom from nausea will be assessed by the number of participants that report the absence of nausea post dose that reported the presence of nausea at baseline.
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.
Description
Pain relief will be assessed using the number of participants that report a pain level of moderate or severe at baseline and then report a pain level of none or mild post dose.
Time Frame
2 hours post-dose
Title
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
Description
Time to first report of pain relief will be based on the first time point a participant reports a pain level of none or mild.
Time Frame
Time to patients first report of pain relief of none or mild post dose up to 48 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s). History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit. Verbally distinguish between migraine and other types of headaches. Participants must have a weight > 40 kg at the Screening Visit. Adequate venous access for blood sampling. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study). Exclusion Criteria: History of cluster headache or hemiplegic migraine headache. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania. History of suicidal behavior or major psychiatric disorder. Current diagnosis or history of substance abuse; positive drug test at Screening. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). Current diagnosis of viral hepatitis or a history of liver disease. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Accel Research Sites-Neurology and Neurodiagnostics of Alabama, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians Research Group
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Individual Site Status
Recruiting
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research, LLC
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
Miller Children's & Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Los Angeles, Division of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital Los Angeles-Children's Hospital Los Angeles Dept of Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Velocity Clinical Research - North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurology Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Davis Midtown Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Pacific Clinical Research Management Group LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado- lnvestigational Drug Services
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dinosaur Junction Pediatrics
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Boeson Research - Grand Junction, CO
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Name
Ki Health Partners, LLc, dba New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Nemours Children's Health
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Nemours Children's Hospital, Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Topaz Clinical Research, Inc.
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Individual Site Status
Recruiting
Facility Name
First Choice Neurlogy Espinosa Neuroscience Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Beautiful Minds Clinical Research Center
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Terminated
Facility Name
DeLand Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Terminated
Facility Name
University Clinical Research - Deland, LLC dba Accel Research Sites
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Terminated
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
Watson Clinic Center for Research, Inc.
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Terminated
Facility Name
Watson Clinic LLP
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Terminated
Facility Name
AppleMed Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Center of Miami II, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurology Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Aqualane Clinical Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Name
Collier Neurologic Specialists, LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Clinical Research Specialists
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Orlando Health Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bioresearch Institute
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Individual Site Status
Terminated
Facility Name
Forcare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta Center for Advanced Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Rare Disease Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Pivotal Clinical Research & Associates, LLC
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExcel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Headache Center & Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Name
AMR-Baber Research Inc
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Clinical Research Center at Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians Research Group
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Research Group, LLC
City
Westfield
State/Province
Indiana
ZIP/Postal Code
46074
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Recruiting
Facility Name
College Park Family Care Center Physicians Group- Neurology Research Dept.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Name
Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology and Headache Center, Inc.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
Outpatient Pediatric Neurology Clinic
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Spectrum Health Helen Devos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wellnow Urgent Care and Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Beaumont Hospital Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharlin Health Neuroscience Research Center
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Physicians
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research HLN
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Individual Site Status
Recruiting
Facility Name
Helena Pediatric Clinic P.C.
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research LLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Moose Pediatrics
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Recruiting
Facility Name
Alivation Research, LLC.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Terminated
Facility Name
Children's Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Prime Global Research, LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Individual Site Status
Terminated
Facility Name
Northwell Health/ Division of Pediatric Neurology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Hospital-Long Island, Clinical Research Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Hospital-Long Island, Pediatric Neurology
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Neurology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Hospital - Pharmacy Department
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Pediatric Neuromuscular Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
North Suffolk Neurology P.C
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Terminated
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Drug Delivery - Cincinnati Children's Hospital IDS - Denise Lagory
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Lynn Institute of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Pediatric Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research-Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
Holston Medical Group.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Access Clinical Trials, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Name
Child Neurology Consultants of Austin - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Individual Site Status
Recruiting
Facility Name
Child Neurology Consultants of Austin - Central Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Clinical Trials, LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Future Search Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Medical Center, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Health Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Recruiting
Facility Name
ANRC Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Pain and Headache Centers of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Clinical Research,LLC.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NeuroCare Plus
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research , LLC(Administrative Location)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Research of Charlottesville, LLC (Regulatory Only)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Recruiting
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital Investigational Drug Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Children's Investigational Drug Service
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Investigation Specialists, Inc
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
OCT Research ULC
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Sherbrooke Inc
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Name
" The First Affiliated Hospital of Chongqing Medical University"
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
" The First Affiliated Hospital of Chongqing Medical University"
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital Lab
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen Children's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518026
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050004
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan City
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The Second People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi Children's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Xuzhou Children's Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University, Pediatric Neurology
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'an Gaoxin Hospital Neurology Department
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710075
Country
China
Individual Site Status
Recruiting
Facility Name
Yan 'an University Xianyang Hospital
City
Xianyang City
State/Province
Shaanxi
ZIP/Postal Code
716000
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Chifeng University
City
Chifeng
Country
China
Individual Site Status
Recruiting
Facility Name
Lu 'an People's Hospital
City
Lu 'an
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Shihezi University School of Medicine
City
Shihezi
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Children's Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Name
Clinstile S.A. de C.V.
City
Col. Roma Norte
State/Province
Ciudad DE Mexico
ZIP/Postal Code
C.P. 06700.
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Reseach Institute, S.C.
City
Tlalnepantla de Baz
State/Province
Estado DE Mexico
ZIP/Postal Code
C.P. 54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigación Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
"Hospital Universitario "" Dr. Jose Eleuterio Gonzalez"" Edificio Barragan 3er Piso CITEN
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
CIT-Neuropsique, S.C.
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
C.P. 64610.
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
800200
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Unidad de Investigacion en Salud de Chihuahua S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
City
Katowice
ZIP/Postal Code
10-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
City
Poznań
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Euromedis Sp. z o. o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
CAP Balenyà
City
Barcelona
ZIP/Postal Code
08550
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47001
Country
Spain
Individual Site Status
Recruiting
Facility Name
ProbarE i Lund
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Recruiting
Facility Name
ProbarE i Stockholm AB
City
Stockholm
ZIP/Postal Code
113 29
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
70362
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
University Hospitals of Leicester - NHS Trust Research - Innovation Leicester General Hospital
City
Leicester
State/Province
Leics
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Cognition Health - London
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital GOSH for Children NHS Foundation Trust - Headache Clinic
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-311
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

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